País: Regne Unit
Idioma: anglès
Font: MHRA (Medicines & Healthcare Products Regulatory Agency)
Amiodarone hydrochloride
Zentiva Pharma UK Ltd
C01BD01
Amiodarone hydrochloride
200mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02030200; GTIN: 5000283598114
PACKAGE LEAFLET: INFORMATION FOR THE USER AMIODARONE 100 MG TABLETS AMIODARONE 200 MG TABLETS (Amiodarone Hydrochloride) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor, pharmacist or nurse. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to you doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Amiodarone Tablets are and what they are used for 2. What you need to know before you take Amiodarone Tablets 3. How to take Amiodarone Tablets 4. Possible side effects 5. How to store Amiodarone Tablets 6. Contents of the pack and other information 1. WHAT AMIODARONE TABLETS ARE AND WHAT THEY ARE USED FOR Amiodarone 100mg or 200mg Tablets (called Amiodarone Tablets in this leaflet) contain a medicine called amiodarone hydrochloride. This belongs to a group of medicines called anti-arrhythmics. It works by controlling the uneven beating of your heart (called ‘arrhythmias’). Taking the tablets helps your heartbeat to return to normal. Amiodarone Tablets can be used to: • Treat uneven heartbeats where other medicines either have not worked or cannot be used • Treat an illness called Wolff-Parkinson-White Syndrome. This is where your heart beats unusually fast • Treat other types of fast or uneven heartbeats known as ”atrial flutter” or ”atrial fibrillation”. Amiodarone Tablets are used only when other medicines can not be used. • Treat fast heartbeats which may happen suddenly and may be uneven. Amiodarone Tablets are used only when other medicines cannot be used. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMIODARONE TABLETS DO NOT TAKE AMIODARONE TABLETS IF • you are allergic (hypersensiti Llegiu el document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Amiodarone Hydrochloride 200mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200mg of amiodarone hydrochloride. Excipient(s) with known effect Lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White, round, bevelled edge tablets, embossed with breakline on one side and plain on the other side with an approximate diameter of 9.5mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment should be initiated and normally monitored only under hospital or specialist supervision. Oral Amiodarone Hydrochloride 200mg Tablets are indicated only for the treatment of severe rhythm disorders not responding to other therapies or when other treatments cannot be used. Tachyarrhythmias associated with Wolff-Parkinson-White Syndrome. Atrial flutter and fibrillation when other drugs cannot be used. All types of tachyarrhythmias of paroxysmal nature including: supraventricular, nodal and ventricular tachycardias, ventricular fibrillation; when other drugs cannot be used. Tablets are used for stabilisation and long term treatment. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology_ _ _ _ ADULTS It is particularly important that the minimum effective dose be used. In all cases the patient's management must be judged on the individual response and wellbeing. The following dosage regimen is generally effective. _Initial Stabilisation_ Treatment should be started with 200mg, three times a day and may be continued for 1 week. The dosage should then be reduced to 200mg, twice daily for a further week. _Maintenance_ After the initial period the dosage should be reduced to 200mg daily, or less if appropriate. Rarely, the patient may require a higher maintenance dose. The dosage should be titrated to the minimum required to maintain control of the arrhythmia. The maintenance dose should be regularly reviewed, especially where this exceeds 200 mg daily. GENERAL CONSIDERATIONS _Initial dosing _ A h Llegiu el document complet